Clinical Operations Manager [WD978]
Pubblicato il 24-01-2025 - Bristol-Myers Squibb in Roma
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
**The Role**
We are looking for the **Clinical Operations Manager** who will lead and manage a **Team of Clinical Trial Monitors regionally based in the North of Italy**. This position will ensure delivery of clinical operations effectiveness in RCO South East Europe and will be based in Milan.
**Key Duties And Responsibilities**
- Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Monitors (CTMo) to ensure timely execution consistent with R&D; and local research goals and priorities
- Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.
- Anticipates resource needs and provides workload evaluations and task assignments
- Allocates and assign study resources in alignment with R&D; and local research goals and priorities.
- Supervises clinical trial execution at country level including supervising study metrics and team performance
- May propose and/or validate country study targets
- May support Health Authority inspection and pre-inspection activities
- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues
- Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available
- Develops goals that are consistent with R&D; and local research goals and priorities and takes necessary actions to ensure that goals are met
- Together with the RCO management tracks and manages performance metrics for Clinical Operations staff
- Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit
- Point of Contact for FSP staff within the country/cluster
- Managing the hiring, performance management and succession planning of staff
- Performing general and human resource administrative functions
- Participation in performance calibration and talent review meetings
- Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)
- When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager
- Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed
**Qualifications, Knowledge and Skills Required**
- ** Bachelors or Master degree required. Field of study within life sciences or equivalent**:
- ** Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs**:
- Significant experience in the planning, conduct and management of clinical programs (Phase I-IV)
- Demonstrated ability to drive project related activities
- Previous supervisory and/or leadership experience (i.e. participation in task force, initiative or cross functional team)
- Previous resource allocation experience preferred
- Experience mentoring and providing feedback to others
- In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
- In depth knowledge and understanding of clinical research processes, regulations and methodology
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
- Demonstrated organizational and planning skills and independent decision-making ability
- Strong organization and time management skills and ability to effectively manage multiple competing priorities
- Outstanding interpersonal, oral and written communication skills to influence, inform or guide others
- Advanced proficiency in English and in Italian
- L’appartenenza alle categorie protette, lg. 68/99 costituirà titolo preferenziale._
**What’s important to us**
Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:
**Passion**_:
Our dedication to learning and excellence helps us to deliver exceptional results. _
**Innovation**: _We pursue disruptive and bold solutions for patients. _
**Urgency**: _We move together with speed and quality because patients are waiting._
**Accountability**: _We